Impress employers and recruiters.
Choose from hundreds of resume examples.

Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

This role is responsible for regulatory submissions for in vitro diagnostics and medical devices, and for developing market entry strategies. The position involves leading the acquisition and maintenance of marketing approval through PMDA consultations and negotiations with regulatory authorities. Additionally, the role handles internal regulatory affairs operations and staff training.

Responsibilities

• Responsible for regulatory submissions for in vitro diagnostics and medical devices (including instruments, reagents, and software)
• Develop market entry strategies in collaboration with related departments
• Lead the acquisition and maintenance of marketing approval through PMDA consultations and negotiations with regulatory authorities (MHLW and PMDA)
• Handle internal regulatory affairs operations, including change control and review of materials and documentation
• Responsible for training and supervising staff

Requirements

• Minimum of 3 years’ experience in regulatory submissions for in vitro diagnostics and medical devices
• Proven track record of proactively expanding scope of responsibilities and delivering results
• Basic knowledge of regulatory laws and regulations
• Ability to interpret data
• Strong logical thinking
• Excellent documentation skills
• Leadership to independently drive projects
• Strong coordination and communication skills with both internal and external stakeholders
• Proactive, growth-oriented mindset with flexibility and willingness to take on new challenges

Skills

• Experience with Software as a Medical Device (SaMD) is strongly preferred
• Academic background in life sciences (e.g., biochemistry, immunology, genetics)
• Proficiency in reading and writing in English
• Spoken English is a plus

Experience Level

• Minimum of 3 years’ experience

Education Level

• Academic background in life sciences (e.g., biochemistry, immunology, genetics)